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510(k) K781644

ANTIBIOTIC NEPHELOMETER by Biovation, Inc. — Product Code JQX

K781644 is an FDA 510(k) premarket notification submitted by Biovation, Inc. for the device "ANTIBIOTIC NEPHELOMETER". The FDA issued a decision of Substantially Equivalent on October 3, 1978. The device falls under product code JQX (Nephelometer, For Clinical Use), a Class I device regulated under 21 CFR 862.2700. Biovation, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 1978
Date Received
September 25, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nephelometer, For Clinical Use
Device Class
Class I
Regulation Number
862.2700
Review Panel
CH
Submission Type

Other clearances by Biovation, Inc.

  • K925528 — BIOVATION K-MANAGER (February 5, 1993)
  • K923844 — LYRIS 100/120 LABORATORY INFORMATION SYSTEM (December 11, 1992)
  • K915071 — DIFFERENTIAL COUNTING BOARD (January 17, 1992)
  • K853026 — BIOVATION MAX DATA MANAGEMENT SYSTEM (August 2, 1985)
  • K842401 — CHEMISTRY CONSOLE (September 4, 1984)
  • K831830 — LYRIS MODULAR INFO SYSTEM (June 25, 1984)
  • K821534 — HEMATOLOGY DATA MANAGEMENT SYS (June 10, 1982)
  • K812604 — BIOVATION URINALYSIS REPORTER (October 2, 1981)
  • K792045 — BIOVATION NEPHELOMETER (October 30, 1979)
  • K790862 — BIOVATION DIGITAL URINOMETER (June 28, 1979)

Other clearances for product code JQX

  • K962294 — IMMAGE IMMUNOCHEMISTRY SYSTEM (August 21, 1996)
  • K922273 — ARRAY(R) 360 (August 19, 1992)
  • K885263 — QMS(TM) - THEOPHYLLINE (March 28, 1989)
  • K851253 — TDX ANALYZER W/NEPHELOMETRY CAROUSEL (April 30, 1985)
  • K851234 — A-JUST TURBIDITY METER (April 29, 1985)
  • K801362 — ALBUMIN NEPHELOMETRIC ASSAY (July 21, 1980)
  • K801089 — J.T. BAKER NEPHELOMETER (May 28, 1980)
  • K792045 — BIOVATION NEPHELOMETER (October 30, 1979)
  • K790103 — NEPHELOMETER, MIC-2000 LASER (March 12, 1979)
  • K781554 — RAD-291 (October 11, 1978)

FDA data resources